Chronic PainNCT05914311
Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
A study testing Suture and Suture and Dermabond in people with Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Suture and Suture and Dermabond
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2023to 26 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age greater than 18
- having a spinal cord stimulator trial lead placement done
- lead placement to be done in the thoracic spine area
Who cannot join
- dermabond allergy
- inability to place 2 leads in subject
- lead placement not in thoracic spine
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration
During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
Read the detailed description
Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain. Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length. During the trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
- Conditions
- Chronic Pain
- Being tested
- Suture, Suture and Dermabond
- Keywords
- Spinal Cord Stimulation (SCS), chronic pain, stimulator
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutureDevice
secures SCS trial leads with a suture
Suture and DermabondDevice
secures SCS trial leads with dermabond and suture
| Study group | Role | What they receive |
|---|---|---|
| Suture Group | Active comparator | secure one of the 2 trial leads with suture only-randomized to left or right Receives: Device: Suture |
| Dermabond and Suture Group | Experimental | secure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right Receives: Device: Suture; Device: Suture and Dermabond |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration Distance of Trial Leads
Migration distance of trial leads anchored with Dermabond and suture versus suture alone will be measured by change in trial lead position as measured in millimeters when comparing initial x-ray after placement versus x-ray taken at lead removal 5-8 days after placement
Measured: From Baseline through Day 8
Secondary outcomes (3)
Patient Satisfaction Score
Patient satisfaction score will be valued on a 0-10 scale, with 0-not satisfied at all up to 10-greatest level of satisfaction. The survey asked general questions about participant satisfaction with the spinal cord stimulator (SCS) trial experience (overall satisfaction with experience), not about participant satisfaction with the Dermabond or suture fixation interventions separately.
Measured: Day 8
Rate of Infection
percent of participants with a higher rate of infection
Measured: Day 8
Number of Patients With Pain Relief
Number of patients who received pain relief from the spinal cord stimulation trial. Number of responders to the prognostic lead placements defined as >50% pain relief over the length of the trial.
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start8 Sep 2023
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlyle Hamsher, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914311
- Sponsor's protocol ID
- IRB00087042
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2023
- Last updated
- 9 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: analysis will include all participant data via publication
Publications
Hurley RW, Patel JS, Bintrim DJ, Oliver JB, Miranda A, Rahmah T, Hamsher CP. Dermabond Versus Suture Fixation for Spinal Cord Stimulator Trial Lead Anchoring: A Randomized Within-Patient Controlled Trial. Pain Med. 2026 Jul 3:pnag083. doi: 10.1093/pm/pnag083. Online ahead of print.
PubMed 42398024
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration
- ClinicalTrials.gov ID
- NCT05914311
- Acronym / sponsor ID
- IRB00087042
- Conditions
- Chronic Pain
- Keywords
- Spinal Cord Stimulation (SCS), chronic pain, stimulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Posted 9 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
Detailed description
Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain. Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length. During the trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture Group | Active comparator | Device: Suturesecure one of the 2 trial leads with suture only-randomized to left or right |
| Dermabond and Suture Group | Experimental | Device: Suture, Device: Suture and Dermabondsecure one of the 2 trial leads to be secured with both dermabond and suture-randomized to left or right |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age greater than 18
- having a spinal cord stimulator trial lead placement done
- lead placement to be done in the thoracic spine area
Key exclusion criteria (3 listed)
- dermabond allergy
- inability to place 2 leads in subject
- lead placement not in thoracic spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suturesecures SCS trial leads with a suture | Device | Dermabond and Suture Group, Suture Group |
| Suture and Dermabondsecures SCS trial leads with dermabond and suture | Device | Dermabond and Suture Group |
Primary outcome
Migration Distance of Trial Leads
Time frame: From Baseline through Day 8
Migration distance of trial leads anchored with Dermabond and suture versus suture alone will be measured by change in trial lead position as measured in millimeters when comparing initial x-ray after placement versus x-ray taken at lead removal 5-8 days after placement
3 secondary outcomes
Patient Satisfaction Score
Time frame: Day 8
Rate of Infection
Time frame: Day 8
Number of Patients With Pain Relief
Time frame: Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42398024Hurley RW, Patel JS, Bintrim DJ, Oliver JB, Miranda A, Rahmah T, Hamsher CP. Dermabond Versus Suture Fixation for Spinal Cord Stimulator Trial Lead Anchoring: A Randomized Within-Patient Controlled Trial. Pain Med. 2026 Jul 3:pnag083. doi: 10.1093/pm/pnag083. Online ahead of print.
- Individual participant dataSharing planned: No. analysis will include all participant data via publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlyle Hamsher, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture and Suture and Dermabond in people with Chronic Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migration Distance of Trial Leads (time frame: From Baseline through Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.